Customer reported issues with iq200 micro images being gray and out of focus.While viewing video, which initially appeared normal, fse observed the video average dropped to 127 from 210 (light level dropping), making images dark.Fse replaced the camera and strobe power sic pcb, performed collimation and tilt adjustment.Fse followed-up with customer and verified that system was operating.No indications that pt results were reported out of lab.No change to pt management and no reports of erroneous urine cells or sediment.As per technical sme, there is a possibility of cells to be either placed in the unclassified section, which upon auto-release of results to the ljs, may not reach the physician, or mis-classification of cells resulting in either false positive or false negative rbc and/or wbcs.
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A subject matter expert assisted in the root cause of light fluctuation on the iq200 instrument.The sme stated, a light fluctuation or image error is a flagged sample on the instrument work list.A flagged sample on the instrument work list cannot be released automatically to the lis per iq200 ifu, iq200 series operators manual page 149 p/n: 3004320 rev.C release date: 07/2012.Therefore the risk control with this error could not lead to any patient harm.
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